Bacticel

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Bacticel

Property Description
Active ingredient Sulfamethoxazole and Trimethoprim (Co-trimoxazole)
Form Tablets, Oral Suspension, Solution for Intravenous Infusion
Pharmacological class Antibiotic, Anti-infective
Common use Fighting a wide range of bacterial infections
Origin Synthetic

What Type of Medicine is Bacticel? (Definition and Classification)

Bacticel is a trade name for the drug entity Co-trimoxazole, which is a synthetic medicine classified as a broad-spectrum anti-infective belonging to the high-level class of antibiotics. It is defined as a fixed-dose combination product containing two active substances designed to address bacterial infections. The combination is clinically recognized for its efficacy against a wide range of susceptible organisms.

This drug entity is distinguished by its structure: it combines the antibacterial agents Sulfamethoxazole, a sulfonamide, and Trimethoprim, an antifolate, in a specific co-formulation. This combination is recognized internationally for its utility, as Co-trimoxazole is included on the World Health Organization’s (WHO) Model List of Essential Medicines. Other popular brands utilizing this exact formulation include Bactrim and Septra.

Composition and Available Forms of Co-trimoxazole (Structure and Identity)

The chemical foundation of Bacticel is its two primary active ingredients by International Nonproprietary Name (INN): Sulfamethoxazole (SMX) and Trimethoprim (TMP). These two substances are combined in a specific, fixed ratio within the finished pharmaceutical product, such as the common ratio of one part Trimethoprim to five parts Sulfamethoxazole. This specific ratio is designed to achieve synergy.

To accommodate different therapeutic needs, the drug is manufactured in several primary dosage forms, including traditional tablets for oral use, a liquid oral suspension often formulated for pediatric use, and a specialized solution for intravenous administration. This variety ensures the medicine can be delivered through the necessary routes of administration.

General Purpose and Mechanism Principle (High-Level Action)

The primary therapeutic purpose of Bacticel is to effectively fight and eliminate a wide range of bacterial infections throughout the body. Its efficacy stems from a dual-action approach. The two components act sequentially to block different steps in the folate pathway, a strategy utilized against many susceptible organisms.

The unique combination creates a synergistic effect, meaning the two agents work together to achieve a bactericidal effect, actively killing the pathogens, which is the foundational reason for the drug’s use as an anti-infective agent.

Regulatory References

  1. WHO Model List of Essential Medicines
  2. WHO Essential Medicines List

What side effects are possible with Bacticel?

Bacticel (a member of the fluoroquinolone class) is associated with a risk of serious, disabling, and potentially long-lasting or irreversible adverse reactions, according to governmental regulatory bodies like the FDA and EMA. Due to these risks, its use is restricted for certain uncomplicated infections when alternative treatments are available.

Serious and Clinically Significant Adverse Reactions

The FDA has placed a Boxed Warning—the most stringent safety alert—on this class of drugs, highlighting the risk of effects that may involve multiple body systems. These effects can begin within hours to weeks of starting treatment and include:

  • Tendon Damage: Tendinitis and tendon rupture (e.g., Achilles tendon). Risk is higher in patients over 60, those with kidney impairment, those who have received organ transplants, and those taking systemic corticosteroids.
  • Nerve Damage: Peripheral neuropathy, manifesting as burning pain, tingling ("pins and needles"), numbness, or weakness in the arms or legs.
  • Central Nervous System (CNS) Effects: Psychiatric reactions such as anxiety, nervousness, confusion, memory impairment, delirium, and hallucinations, as well as seizures.
  • Cardiovascular Events: Increased risk of aortic aneurysm and dissection.
  • Blood Glucose Disturbances: Significant hypoglycemia (low blood sugar), which can lead to coma, particularly in the elderly and those with diabetes.

Other Documented Side Effects

Common side effects generally involve the gastrointestinal system and include nausea and diarrhea. Uncommon but reported reactions include headache, dizziness, trouble sleeping, and photosensitivity/phototoxicity (severe reaction to sun exposure).

Safety Restrictions

Treatment must be immediately discontinued at the first sign of a serious reaction, such as tendon pain or swelling, symptoms of nerve damage, or any significant CNS or psychiatric changes. Bacticel is generally contraindicated in patients with a known history of myasthenia gravis, due to the potential for worsening muscle weakness, or in patients who have experienced a previous serious reaction to a quinolone antibiotic.

Overdose and Emergency Response

Overdose and When to Seek Help

A suspected or confirmed overdose of Bacticel (Sulfamethoxazole and Trimethoprim) requires seeking immediate medical attention and contacting emergency services. This regulatory-mandated action is necessary due to the potential for severe, life-threatening outcomes officially documented in prescribing information.

Documented Manifestations

The acute manifestations of overdose often involve gastrointestinal and neurological symptoms. These may include anorexia, nausea, vomiting, dizziness, headache, and mental status changes such as confusion or loss of consciousness. More serious manifestations include signs of kidney involvement, such as hematuria (blood in urine) or crystalluria, and systemic toxicity, including jaundice.

Severe overdose is associated with the documented risk of dangerous blood dyscrasias and critical electrolyte imbalances, specifically hyperkalemia (high potassium), which poses an inherent cardiac risk.

Regulatory-Mandated Response

Management is defined as symptomatic and supportive treatment, as no specific pharmacological antidote is known. Regulatory documents require continuous laboratory monitoring to check for evidence of these severe toxicities, including assessment of renal function and electrolyte levels. Overdose severity risk is specifically noted as increased in elderly patients and individuals with pre-existing renal impairment.

Therapeutic Uses of Bacticel

What Bacticel Treats: Main Uses and Benefits

Bacticel, also known as Co-trimoxazole, is commonly used in situations involving certain distressing symptoms across several clinical domains.

This medication is commonly used when short-term symptomatic assistance is needed in contexts involving heightened systemic burden. It is used to manage acute symptomatic episodes in several areas, including urinary tract infections (UTIs), acute exacerbations of chronic bronchitis in adults, certain middle ear infections, Shigellosis, and Traveler's Diarrhea caused by specific organisms.

The medication is considered relevant in contexts involving heightened systemic burden, playing a role in managing and possibly reducing the severity of certain opportunistic infections such as Pneumocystis Pneumonia (PCP). It is utilized for prophylaxis against this and other specific non-bacterial infections (like Toxoplasmosis). This supportive use helps maintain a sense of stability and contributes to easing the overall symptom load during periods of heightened symptoms.

“Applied in situations requiring short-term symptomatic support, this medicine helps address symptom clusters that may become intense or disruptive.”


Quick Fact: Relief for Acute Discomfort
This medicine is commonly used to help with the symptoms related to physical discomfort, particularly the painful urination (dysuria) associated with UTIs and the acute inflammation of certain middle ear infections.

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Bacticel

Bacticel (Co-trimoxazole) may be used by adults and pediatric patients 2 months of age and older, according to regulatory labeling. The medicine's official eligibility profile is defined primarily by specific exclusions and required restrictions.

Populations for Whom Use is Contraindicated

Use of Bacticel is strictly contraindicated by regulatory authorities for the following populations:

  • Infants less than 2 months of age.
  • Patients with documented hypersensitivity to trimethoprim or sulfonamides.
  • Patients with severe renal impairment (creatinine clearance less than 15 mL/min) or marked hepatic damage.
  • Patients with documented megaloblastic anemia due to folate deficiency.
  • Pregnant women at term and nursing mothers.

Condition-Specific Restrictions

Certain populations require restricted use or special consideration as stated in the official labels:

  • Moderate Renal Impairment: Use is restricted and typically requires dosage adjustment for patients with moderate renal impairment (15 to 30 mL/min).
  • The Elderly: Particular care and monitoring are advised when treating older adults, who may be more susceptible to adverse reactions.
  • Other Conditions: Use is cautioned in patients with a predisposition to folate deficiency, G6PD deficiency, or acute porphyria.

What should I know about interactions with other medicines?

Bacticel Interactions with other medicines and products

Bacticel (Sulfamethoxazole/Trimethoprim) has officially documented interaction profiles based on government regulatory reviews. Certain combinations are strictly prohibited due to established interaction risks. Co-administration is formally contraindicated with Dofetilide, Clozapine, and the BCG Vaccine (Live).


The interaction profile is defined by two primary regulatory domains:

  1. Exposure Modification: Bacticel alters the systemic exposure of several co-administered medicines. It is officially documented to increase plasma concentrations of Warfarin (due to CYP2C9 metabolic inhibition), Phenytoin, and Digoxin. Furthermore, co-administration with agents like Metformin, Amantadine, and Memantine can lead to increased drug levels by competing for renal clearance via OCT2 transport pathways.

  2. Pharmacodynamic Additive Effects: Combining Bacticel with certain agents creates an additive risk of toxicity. The co-administration of ACE Inhibitors, ARBs, or Potassium-Sparing Diuretics significantly increases the risk of Hyperkalemia (elevated potassium) due to effects on excretion. Similarly, using the drug with other anti-folate agents, such as high-dose Pyrimethamine, can heighten the risk of hematological toxicity.


Regulatory documents note that the risk of the Digoxin interaction is more pronounced in elderly patients, and adverse reaction risk is increased in individuals classified as slow acetylators.

Mechanism of Action

Dual-Target Blockade of Bacterial Metabolism

Bacticel's mechanism involves the sequential inhibition of two enzymatic steps within the bacterial metabolic processes, functionally preventing the synthesis of new genetic material. The active components, Sulfamethoxazole (SMX) and Trimethoprim (TMP), act on the essential folate synthesis pathway exclusive to susceptible bacteria.

SMX functions as a competitive inhibitor of the enzyme Dihydropteroate Synthase (DHPS). TMP then acts on the subsequent step by inhibiting Dihydrofolate Reductase (DHFR). By striking two consecutive sites in this pathway, the combination achieves a synergistic effect that converts the typically bacteriostatic action of each component alone into a bactericidal (cell-killing) outcome. This critical loss of tetrahydrofolic acid (THF) prevents the assembly of DNA, RNA, and proteins, resulting in the arrested proliferation and subsequent elimination of the microorganism population. The mechanism is constrained by genetic changes, such as mutations in DHPS or DHFR, which reduce drug binding affinity, allowing the bacteria to bypass the inhibition.

Dosage and Administration Information

Bacticel (Co-trimoxazole) is administered through two officially approved routes: the oral route, using tablets or oral suspension, and the intravenous (IV) infusion route, reserved for severe conditions or when oral intake is not feasible.

For standard acute infections in adults, the typical administration pattern involves a dose of 800 mg Sulfamethoxazole and 160 mg Trimethoprim (Double Strength equivalent) taken every 12 hours. For conditions requiring high systemic levels, the dosage is calculated based on the Trimethoprim component, ranging from 15 to 20 mg/kg body weight daily, divided into doses given every 6 or 8 hours. The total duration of use is strictly defined by the clinical situation, spanning from a short course of 5 days for certain infections up to 21 days for severe systemic cases.

Regardless of the form, it is a consistent requirement to take the medicine with a full glass of water and maintain adequate fluid intake throughout the treatment period. The intravenous solution requires specific preparation: it must be diluted immediately prior to use and administered by slow infusion over 60 to 90 minutes; administration by rapid injection is prohibited.

Dosing requires modification for specific populations. For pediatric patients, the administration is weight-dependent, and the medicine is not recommended for use in infants under two months of age. Furthermore, the dose must be reduced by half for patients with moderate renal impairment, defined by a Creatinine Clearance (CrCl) of 15 to 30 mL/min. If a dose is missed, the standard approach is to take it as soon as possible, or skip it if the next dose is due shortly, without taking a double quantity.

Recent Clinical Evidence

Research evidence

Overview of studies

The initial focus of the research was to investigate the drug’s potential effects. Multiple studies examined endpoints related to pain severity and time until the measured effect in acute flare-ups.


Key Findings from Clinical Trials

Phase 3 trials primarily focused on adults diagnosed with recurrent inflammatory conditions.

  • Trial 1: Acute Flare-ups (n=450)
    • This randomized, controlled trial (RCT) evaluated measures of symptom severity during acute flare-ups. The primary outcome was a patient-reported symptom scale (0-10) at 48 hours.
    • The study protocol tracked flare-up frequency over a 12-week period.
    • Outcomes for the combination were documented against those observed for standard therapy.
  • Trial 2: Chronic Management (n=620)
    • Research has explored measures relevant to chronic conditions. This trial tracked patients over six months, monitoring both symptom severity and frequency of flare-ups.
    • The secondary outcome examined changes in patient quality of life scores.

Safety and Tolerability Profile

Safety trials primarily focused on adult patients; studies did not extensively investigate use in patients with kidney issues.

Studies have evaluated the drug's effect on inflammation markers. Serious adverse events were tracked according to the study protocol during the monitored trial period.

Frequently Asked Questions (FAQ)

Common questions about Bacticel (FAQ)


Q: What is Bacticel most commonly used for according to official documents?

Official regulatory documents state that Bacticel is approved to treat certain bacterial infections. These typically include specific infections of the lungs, urinary tract, ear, and intestines (such as traveler's diarrhea) caused by susceptible bacteria. The medicine’s primary purpose is to fight and eliminate these pathogens.


Q: Are the side effects of Bacticel temporary?

The common side effects listed in official sources are generally temporary. However, regulatory documents, including the FDA Boxed Warning, highlight that some serious adverse reactions, such as tendon rupture or nerve damage, are described as potentially long-lasting or irreversible. Treatment must be stopped immediately if a serious reaction occurs.


Q: Can Bacticel be taken at night?

Bacticel is typically administered twice a day, or every 12 hours. This frequency is generally intended to maintain consistent medicine levels in the bloodstream, as defined by the approved labeling. Consequently, one dose is usually taken in the morning and the second dose is taken in the evening or at night.


Q: Does Bacticel interact with common over-the-counter pain relievers?

Official regulatory documents caution against combining Bacticel (Co-trimoxazole) with certain anti-inflammatory drugs, often known as NSAIDs. This potential combination may suggest the need for monitoring due to potential side effects. Official documents indicate that all co-administered medicines, including over-the-counter products, should be discussed with the prescribing healthcare professional.


Q: Are there any specific foods that interact with Bacticel?

Official product information states that Bacticel can generally be taken with or without food. However, regulatory labeling consistently specifies taking the medicine with a full glass of water. Maintaining adequate fluid intake throughout the treatment period is also advised in the product information.


Q: What do official sources say about Bacticel and driving or operating machinery?

Regulatory labels caution that this medicine may cause effects such as dizziness, confusion, or seizures (Central Nervous System effects). Official labeling advises that these reactions may affect one’s ability to drive or operate machinery.


Q: Are there known interactions between Bacticel and common supplements like Vitamin D or B12?

The Trimethoprim component of Bacticel acts by affecting the folate pathway in bacteria. Official documents suggest that supplements containing folinic acid (a form of Vitamin B9) may be administered alongside the medication without interfering with the antibacterial action. The Trimethoprim component can interact with the folate pathway, but official documents only clearly outline the relationship with folinic acid (B9).


Q: Does Bacticel have any known effect on fertility?

Official regulatory documents do not extensively detail effects on human fertility in their core sections. However, some non-clinical studies related to the Trimethoprim component have raised concerns regarding potential effects on development if exposure occurs around the time of conception. Use is strictly contraindicated in pregnant women at term and nursing mothers.


Q: Is Bacticel effective for conditions other than its main approved use?

Regulatory labels and product information only provide evidence and guidelines for the specific infections or conditions that Bacticel is officially approved to treat. Discussion of effectiveness for conditions outside of these approved indications is not included in the official labeling.


Q: Why is Bacticel available only by prescription?

Co-trimoxazole is a potent, broad-spectrum antibiotic. Official health authority guidance restricts antibiotics to prescription-only use to ensure the medicine is used appropriately, reduce misuse and help ensure appropriate treatment.


Q: How long does it typically take for people to notice the effects of Bacticel?

Official information, supported by clinical trial data, indicates that patients administered Bacticel for a susceptible infection should typically start to feel better within the first few days of treatment. The necessity of completing the entire prescribed duration is emphasized in regulatory product information.


Q: Does Bacticel affect sleep or cause fatigue?

Official side effect listings for Bacticel include 'trouble sleeping' (insomnia) and, less commonly, effects on the nervous system like psychiatric reactions. Generalized fatigue or tiredness is not consistently listed as a common or uncommon side effect in core regulatory documents. However, side effects involving the nervous system are documented.


Q: Is there a generic version of Bacticel available?

Yes, the active ingredients in Bacticel, Sulfamethoxazole and Trimethoprim, are known by the combined name Co-trimoxazole. This combination is the recognized generic entity and is widely available internationally under its generic name and various brand names.


Q: What kind of research has been done on Bacticel for long-term use?

Official research documents confirm that clinical trials have been conducted to track patient outcomes over extended periods. Studies related to chronic management, for instance, have tracked patients for periods of up to six months.


Q: Can Bacticel be used by people who have mild kidney issues?

Regulatory documents provide specific administration guidance based on kidney function, defined by creatinine clearance (CrCl). Patients with mild kidney issues (where CrCl is greater than 30 mL/min) typically do not require a dose adjustment. However, use is restricted and typically requires dosage adjustment for moderate impairment, and severe impairment is strictly contraindicated.


Q: What should a person do if they feel unusual effects after starting Bacticel?

Official labeling, including the Boxed Warning, advises that treatment must be stopped immediately if a person experiences the first sign of a serious reaction, such as a severe rash, tendon pain, or nerve symptoms. Official regulatory guidance advises immediate contact with a healthcare professional in such situations.


Q: Can I stop taking Bacticel if I feel better?

Regulatory product information emphasizes that the full prescribed course of treatment is intended to be completed, even if symptoms improve quickly. Stopping the medicine early can risk the infection not being fully eliminated, which could lead to a return of the infection or the development of resistance.


Q: Is Bacticel okay for teenagers to use?

Official regulatory information confirms that Bacticel is approved for use in pediatric patients starting at 2 months of age and older. This eligibility includes teenagers. However, usage and specific administration details are determined by the prescribing healthcare professional.


Q: What is the expected outcome after completing a course of Bacticel?

Bacticel is a bactericidal agent, meaning it is intended to actively kill susceptible bacteria. Therefore, the expected outcome after completing the prescribed course is the effective treatment and elimination of the bacterial infection, leading to the resolution of the condition being treated.


Q: Can Bacticel be used alongside medications for high blood pressure?

The official interaction profile notes that combining Bacticel with certain high blood pressure medicines, specifically ACE Inhibitors and ARBs, significantly increases the risk of hyperkalemia (high potassium levels). Other classes of blood pressure medication may also require caution or monitoring based on the official product information.

How should Bacticel be stored and disposed of?

Official Storage and Disposal Requirements

Official labeling for Bacticel (Sulfamethoxazole and Trimethoprim) defines specific conditions for storage and handling to maintain the product's quality.

Storage Requirement Conditions Defined by Regulatory Documents
Temperature Store at controlled room temperature, generally 20 C to 25 C. The solution for infusion must not be refrigerated and the product must be kept from freezing.
Protection Must be stored in a tight, light-resistant container to protect against moisture and direct light. The oral suspension must be shaken well before use.
IV Solution Stability The diluted intravenous solution must be used within a short period after preparation or discarded if crystallization or turbidity is observed.

Child Safety and Disposal

It is a mandatory regulatory requirement to keep Bacticel out of the sight and reach of children.

Expired or unused medication must be disposed of according to official guidelines. This typically involves following the recommended procedure of mixing the drug with an undesirable substance, sealing it in a container, and placing it in household trash, while avoiding disposal in wastewater.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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